OWU

Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia

Product code
OWU
Device name
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant

FDA classification definition

For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OWU
Classification and pathway per current FDA publications. Data from openFDA (CC0).